Daiichi Sankyo's anti-clotting drug shows promise in Ph III CAD study

Japanese drug major Daiichi Sankyo (TYO: 4568) presented positive results of the PRASFIT-Elective Phase III study for its antiplatelet agent prasugrel hydrochloride in patients with coronary artery disease at the 22nd Annual Meeting of the Japanese Association of Cardiovascular Intervention and Therapeutics.

The incidence of the composite primary endpoint (cardiovascular death, non-fatal myocardial infarction, ischemic stroke) was 4.1% in the prasugrel group versus 6.7% in the clopidogrel sulfate group. The incidence of non-CABG (coronary artery bypass graft) Thrombolysis In Myocardial Infarction (TIMI) major, minor or clinically relevant bleeding was 5.4% in the prasugrel group versus 6.2% in the clopidogrel cohort. The incidence of non-CABG TIMI major bleeding in the prasugrel group was 0.0% while in the clopidogrel group, it was 2.2%. The efficacy and safety results of this study are similar to those of the PRASFIT-ACS study.

Japan NDA filed in June

In June, Daiichi submitted a New Drug Application to Japan’s Ministry of Health, Labor and Welfare for prasugrel for the treatment of patients with ischemic heart disease undergoing percutaneous coronary intervention (PCI) based on the results of the PRASFIT-ACS and PRASFIT-Elective studies (The Pharma Letter June 18). Analysts at Credit Suisse have a net present value for prasugrel of 78.19 yen per share (4% of total) for Daiichi Sankyo.